MUNDIPHARMA

New Guidance From ADA and EASD Recommends Use of Sodium-Glucose Co-Transporter-2 (SGLT2) Inhibitors and Glucagon-Like Peptide-1 (GLP-1) Receptor Agonists for Patients with Type 2 Diabetes

As the European distributor of INVOKANA®
(canagliflozin) and VOKANAMET®
(canagliflozin and
metformin) Mundipharma welcomes the news that SGLT2i’s, including
canagliflozin, have now been included as an important treatment option
in the newly published 2018 ADA/EASD Consensus Report in the early
management of T2DM patients with established ASCVD, HF, CKD and also in
patients without cardiovascular disease (CVD) especially where there is
a compelling need to minimize weight gain or promote weight loss or a
need to minimize the risk of hypoglycaemia. The new guidance was
co-published in Diabetologia, the journal of EASD, and Diabetes Care,
the journal of the ADA, during the annual meeting of EASD in Berlin,
Germany on October 5.1

Updates to the guidance took into consideration recent evidence from
large CV outcome trials (CVOTs), which included the CANVAS programme,
the largest completed and published CV outcomes trial to date for an
SGLT2i, which has shown that canagliflozin reduces the risk of major
adverse cardiovascular events (MACE) including CV mortality, non-fatal
myocardial infarction or non-fatal stroke in patients with T2DM who had
either a history of CV disease or at least two CV risk factors, as well
as reducing hospitalisation for heart failure (HHF) and demonstrating
improved renal outcomes.2

“The new guidance puts patients at the centre of care and helps
clinicians to make informed treatment decisions that are aligned to the
needs of each individual and emphasise the importance of clinicians
providing personalised treatment options. There is a lot of excitement
to see the future potential of this class of drugs in improving outcomes
for patients with type 2 diabetes,” said Paul Schofield, European
Medical Lead, Diabetes.

The positioning of canagliflozin within the Consensus Report has been
supported by the recent European Commission approval to expand the
canagliflozin label which was based on the positive results from the
CANVAS Programme.2
The study included 10,142 patients with a
history of CV disease or at least two risk factors of a CV event and
showed canagliflozin met the primary outcome demonstrating a reduction
in the combined risk of major adverse CV events (MACE) by 14% and, as a
secondary outcome, a HHF reduction of 33%. In addition, there were renal
outcomes benefits, seen as a reduction in the doubling of serum
creatinine, the need for renal-replacement therapy and renal death by
47%. The study also demonstrated a 27% reduction in the progression of
albuminuria in people with T2DM with either a history of CV disease or
at least two CV risk factors.3,4
Canagliflozin provided
sustained positive effects on glycaemic and blood pressure control, as
well as weight reduction, demonstrating wide-ranging durability.

#ENDS#

Notes to editors

About the new guidance

The American Diabetes Association (ADA) and European Association for the
Study of Diabetes (EASD) convened a panel to update the position
statements, published in 2012 and 2015
,
on the management of T2DM in adults. The updated consensus
paper
was co-published in Diabetologia, the journal of EASD, and
Diabetes Care, the journal of the ADA, during the annual meeting of EASD
in Berlin, Germany on 5th
October 2018.1

The major changes from prior consensus reports are based on new evidence
from large CV outcome trials which have shown that specific SGLT2
inhibitors or glucagon-like peptide-1 (GLP-1) receptor agonists improve
CV outcomes, as well as secondary outcomes such as HF and progression of
renal disease, in patients with established CVD or CKD.

About the CANVAS programme

The CANVAS programme (N=10,142) comprised the two large canagliflozin
cardiovascular outcome trials, CANVAS and CANVAS-R, and included a
pre-specified integrated analysis of these two studies to evaluate the
potential for CV protection of canagliflozin in patients with T2DM who
had either a prior history of CV disease or at least two CV risk
factors. The integrated analysis also evaluated the effects of
canagliflozin on renal and safety outcomes.3,4

Adverse events reported in the CANVAS programme were generally
consistent with the known safety profile of canagliflozin.3
However,
the study found that, in patients with T2DM who had established CV
disease or at least two risk factors for CV disease, canagliflozin was
associated with an approximately 2-fold increased risk of lower limb
amputation with the rate of amputation over standard of care being
0.63/100 patient years for canagliflozin versus 0.34/100 patient years
for placebo which corresponds to an additional risk of 0.29/100 patient
years. The risk of amputations across the class has previously been
investigated by the EMA, and this is reflected in a warning in the
labelling of all SGLT2 inhibitors.3,4

About INVOKANA®

INVOKANA®
(canagliflozin) is an oral, once-daily medication
which belongs to a new class of medications called sodium glucose
co-transporter 2 (SGLT2) inhibitors. SGLT2 inhibitors work by inhibiting
SGLT2, which promotes the loss of glucose via the urine, lowering blood
glucose levels in adults with T2DM. Canagliflozin was approved in the
European Union by the European Commission in November 2013. INVOKANA®
is indicated for the treatment of adults with insufficiently controlled
T2DM as an adjunct to diet and exercise, as monotherapy when metformin
is considered inappropriate due to intolerance or contraindications and
in addition to other medicinal products for the treatment of diabetes.
Approval was based on a comprehensive global Phase III clinical trial
programme.2

About the Mundipharma network

The Mundipharma global network of privately-owned independent associated
companies was founded in 1956 by doctors and now operates in over 120
countries worldwide. We are focused on developing business partnerships
to identify and accelerate meaningful technology across an increasingly
diverse portfolio of therapy areas including respiratory, oncology,
pain, and biosimilars. Consistent with our entrepreneurial heritage, we
like to think we see what others don’t by challenging conventional
wisdom and asking different and challenging questions. By working in
partnership with all our stakeholders, the Mundipharma network develops
medicines that create value for patients, payers and wider healthcare
systems.

1
Davies, M et al. Management of hyperglycaemia in type 2
diabetes. A consensus report by the American Diabetes Association (ADA)
and the European Association for the Study of Diabetes (EASD). Diabetes
Care, October 2018; Volume 41, Issue 10; 1-33. Last accessed October
2018.2
INVOKANA SmPC. Available at: https://www.ema.europa.eu/documents/product-information/invokana-epar-product-information_en.pdf
Last accessed October 2018.3
Perkovic, V et al.
Canagliflozin and renal outcomes in type 2 diabetes: results from the
CANVAS Programme randomised clinical trials, 2018; The Lancet Diabetes &
Endocrinology. Last accessed October 2018.4
Neal B et
al. Canagliflozin and cardiovascular and renal events in type 2
diabetes: The New England Journal of Medicine. 2017; 377:644-657. Last
accessed October 2018.